Ibudilast for the Treatment of Alcohol Use Disorder

Alcohol Use Disorder Clinical Trial

Official title: A Randomized Controlled Clinical Trial of the Neuroimmune Modulator Ibudilast for the Treatment of Alcohol Use Disorder

Status Completed

Clinical Trial Summary

This study is a double-blind, placebo-controlled randomized clinical trial of IBUD (50mg BID) for the treatment of Alcohol Use Disorder (AUD). Eligible participants will undergo a 12-week medication treatment period and 5 in-person visits over 16 weeks.

Clinical Trial Description

The study design consists of a 12-week, double-blind, placebo-controlled randomized clinical trial of IBUD (50mg BID) for the treatment of Alcohol Use Disorder (AUD). The investigators will randomize 132 treatment-seekers with current AUD over the course of 4 years. As a behavioral support platform, all participants will complete the NIAAA-developed and computer-delivered program "Take Control" during the study. Participants will complete telephone screening, followed by in-person eligibility assessment, a physical exam for medical eligibility, randomization to study medication or matched placebo, and in-person follow-up visits at 4, 8, and 12 weeks of treatment. TLFB assessment of drinking outcomes will also occur by telephone on weeks 2, 6, and 10. A final safety check visit will occur on week 16, consisting of repeated clinical labs and ECG. ;

Related Conditions & MeSH terms

• Alcohol Drinking
• Alcohol Use Disorder
• Alcoholism

• NCT number: NCT03594435
• Study type: Interventional
• Source: University of California, Los Angeles
• Status: Completed
• Phase: Phase 2
• Start date: October 1, 2018
• Completion date: April 19, 2023